A surfeit of obesity experts on the panel could swing the outcome either way. They may look at lorcaserin's weak efficacy and safety risks and vote against the drug; or they might take a sympathetic view, as Haley theorizes, and decide they want more pharmacological options to treat obesity. If that happens, lorcaserin could get a positive vote.
I've observed all of the obesity drug panels over the past two years and I haven't seen much doe-eyed sympathy expressed by obesity experts. On the contrary, they're a tough crowd to please, scarred by the troubles and scandals of previous weight-loss drugs, eager not to repeat the same mistakes.
While Thursday's panel is about lorcaserin, I suspect Vivus' Qnexa will play an indirect role in the deliberations. These panel experts and FDA know that Qnexa is likely to be approved soon, which means the need for a pharmacological option to treat obesity is not unmet for long. This raises the regulatory bar on lorcaserin.
@torams asks, "Hi Adam, what's your opinion on ALXA FDA approval."
(ALXA - Get Report)
is expected to hear from FDA later today on the approval decision for Adasuve, an inhaled therapy for the treatment of agitation in patients with schizophrenia.
My guess: FDA rejects Adasuve.
After this column was written, FDA rejected Adasuve due to unresolved manufacturing problems.
While on the topic of FDA Drug Approvals, I want to formally congratulate the winners in my
FDA Drug Approval Contest
. As you may recall, 60 contestants battled over the past four months to see who could most accurately predict the results of 15 FDA drug approval decisions.
Taking the top prize with an astonishing 14-1 record was Clay, a Texas accountant and avid biotech investor. [He prefers his last name not be disclosed because he's afraid the paparazzi will be camped outside his house.] He is on Twitter, handle @cbhwatch.
Clay's only mis-step in the contest was getting the
Qnexa decision wrong. He predicted approval but as we know, FDA delayed the decision by three months. He may end up being right, but rules are rules, so Clay has one tiny blemish on what is still an amazing achievement. Well done!
Second place, with a 13-2 record, goes to Adam Burden, a secondary school teacher in Auckland, New Zealand. He's also the founder of
, a web site which tracks drug and regulatory catalysts.